MAUDE Adverse Event Report: MICROVENTION, INC. AZUR 35 CX DETACHABLE; VASCULAR EMBOLIZATION DEVICE

Model Number	45-750609
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance's associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not available for return to the manufacturer for analysis.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that the vascular embolization coil implant was used in a procedure for treating a cephalic vein branch to better the flow in a lower left forearm native fistula.Once access was gained to the target cite, one coil was successfully deployed in normal fashion without any issues.The physician then determined another coil was needed to fully shut down flow in the side branch.A second coil was then opened and delivered through the same microcatheter and deployed in normal fashion.The procedure was completed when the physician noticed a short filament of the 6x9 coil that had unraveled from the main coil pack.It was still attached but out of position.Several attempts were made using different devices to push the filament into the coil pack and back into position, but these attempts failed.A snare device was then passed with additional attempts to push the filament back into place, which was successful.All wires and products were removed with some final runs under fluoroscopy confirming the coil filament was maintaining position within the main coil pack.Reportedly, the patient was in good condition at the end of the procedure and was sent to recovery.

• Brand Name: AZUR 35 CX DETACHABLE
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12063373
• Report Number: 2032493-2021-00253
• Device Sequence Number: 11762224
• Product Code: KRD
• UDI-Device Identifier: 00812636021034
• UDI-Public: (01)00812636021034(11)200403(17)250331(10)2004035K2
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 45-750609
• Device Catalogue Number: 45-750609
• Device Lot Number: 2004035K2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 99